Abbott Laboratories’ Humira (adalimumab) has been given the green light of approval in Europe for treating patients with psoriatic arthritis, a condition whereby the symptoms of arthritis are combined with the symptoms of psoriasis. In addition, the company is clearly excited by a second approval - for use as a first line therapy in severe, early rheumatoid arthritis – which opens the door to a significantly larger marketplace for the drug.
The psoriatic arthritis label was awarded on the back of data from the so-called Adept trial, showing Humira improved both joint and skin symptoms in patients, as well as their quality of life [[13/06/05f]]. Meanwhile, the Premier study in severe, early RA showed a significant benefit to the signs and symptoms of RA while taking Humira in combination with methotrexate. Specifically, 62% of those receiving the combination therapy achieved a 50% improvement in their RA symptoms, versus 46% treated with methotrexate alone [[23/12/04e]].
Humira will be made immediately available in Germany, the UK, Spain, Finland and Denmark, and a roll-out across the remaining European Union countries is scheduled to take place in the coming months as each adopts pricing and reimbursement policies.
Abbott is also seeking US clearance for these expanded indications, with a decision due before the end of the year [[17/12/04f]], [[23/12/04e]]. A thumbs-up will likely trigger an explosion in sales of the product, which saw a 58% surge in the second quarter to $321 million as a second line therapy in patients with severe RA who have failed on methotrexate [[14/07/05c]], [[11/09/03b]], [[06/01/03g]].